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Orphans

The Institute of Medicine first floated the National Vaccine Authority idea nearly 10 years ago and is still its most outspoken advocate. Strong support also comes from the Gilmore Commission, an advisory panel established by Congress in 1998 to suggest better responses to terrorism, and an independent panel that in 2000 evaluated the military’s fractured vaccine production system. The bottom line in each analysis is the bottom line: the market for vaccines is too weak for private investments to sustain it. “Sooner or later we have to come to grips with the fact,” says Shine.

Take anthrax. Until recently, there was hardly any market for this vaccine-and no commercial producer to make it. For decades, the Pentagon contracted with a laboratory owned by the state of Michigan to manufacture the vaccine, but that lab repeatedly ran afoul of U.S. Food and Drug Administration regulations. In 1998, the state finally sold the lab to a private outfit, BioPort, a new company backed by investors who had deep ties to the U.S. and British militaries. But the U.S. Department of Defense’s stockpile of vaccine began to dwindle as BioPort renovated the aging facilities. When the anthrax attacks occurred in October 2001, the plant still had not received final regulatory approval, and the Defense Department had so little vaccine on hand that it had suspended its own mandatory anthrax vaccination of all troops. Though the FDA has since given BioPort the green light, anthrax vaccine remains a scarce commodity.

September 11 also brought smallpox into sharp focus. The government’s stockpile of the original smallpox vaccine is nowhere near enough to protect the entire U.S. population, and no big pharmaceutical company has manufactured it since 1982. And though the Departments of Defense and Health and Human Services have each contracted with a different company to make a new smallpox vaccine, it will be several years before they see any results. The Department of Defense has also instructed its contractor to make vaccines against several other potential bioweapons, but that process is so cumbersome that it could easily take a decade before the first of these can be proved safe and effective.

And the problems don’t stop with rarely used bioweapon vaccines. American children receive a battery of vaccines to combat 11 diseases, many of which have thus become uncommon. But in the past year, shortages have occurred with four of these vaccines for a wide variety of reasons (see “Vaccine Shortfalls”). It is too early to assess the extent of the shortages, but many witnesses at the November 27 hearing, as well as senators themselves, made it clear that they are real.

Democratic senator Jeff Bingaman reported that in his home state of New Mexico there is a shortage of tetanus boosters for 11- to 15-year-olds. An epidemiologist representing the Association of State and Territorial Health Officials testified that because of a vaccine shortage, Tennessee could not enforce its requirement that children in day-care facilities be immunized against pneumococcal disease. He added that a diphtheria vaccine shortage “has plagued all states,” and that a shortage of pertussis vaccine forced Colorado to suspend a requirement that children receive fourth and fifth booster doses. With influenza vaccines-which face delivery problems every year, since they must annually be made anew to combat the latest flu strains-unusually severe delays in 2001 have left many elderly people without protection.

In some ways, the problem is the fault of the lawmakers themselves, caused by legislative fine print. Regulators have long recognized that pharmaceutical manufacturers lack the financial incentive to make treatments for diseases that affect only a small fraction of the population. Congress attempted to rectify this in 1983 by passing the Orphan Drug Act, which subsidizes research and development for “orphan” medicines, defined as drugs that treat diseases affecting fewer than 200,000 people in the United States, or drugs whose U.S. sales aren’t expected to cover the cost of development. But vaccines aren’t covered by this law, and there is no comparable “orphan vaccine” act. This means that without the economic incentives of a large potential market, industry will step up to the plate only when the government offers contracts to make specific vaccines.

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Tagged: Biomedicine

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